United States· US:50580-338_490ec903-14a6-e576-e063-6294a90a6d13
IMODIUM
A medicinal product containing loperamide hydrochloride; dimethicone, registered in United States by Kenvue Brands LLC.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- LOPERAMIDE HYDROCHLORIDE; DIMETHICONE
- Manufacturer
- Kenvue Brands LLC
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- August 30, 2026
Packs & prices · 10
- ndc1150580-338-06
- ndc1150580-338-12
- ndc1150580-338-18
- ndc1150580-338-61
- ndc1150580-338-64
- ndc1150580338061 BLISTER PACK in 1 CARTON (50580-338-06) / 6 TABLET in 1 BLISTER PACK
- ndc1150580338122 BLISTER PACK in 1 CARTON (50580-338-12) / 6 TABLET in 1 BLISTER PACK
- ndc1150580338183 BLISTER PACK in 1 CARTON (50580-338-18) / 6 TABLET in 1 BLISTER PACK
- ndc1150580338614 BLISTER PACK in 1 CARTON (50580-338-61) / 6 TABLET in 1 BLISTER PACK
- ndc1150580338644 BLISTER PACK in 1 CARTON (50580-338-64) / 6 TABLET in 1 BLISTER PACK
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Loperamide hydrochloride; dimethicone in 4 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- SwitzerlandImodium duo, TablettenJNTL Consumer Health II (Switzerland) GmbH
- SwedenDimor Comp 2 mg/125 mg TablettNordic Drugs AB
- GermanyImodium Akut DuoKenvue Germany Gmbh
- NorwayImodium CompMcNeil Sweden AB
Authorised across Europe · EMA
The same active substance is authorised in 24 EEA countries. Names it is sold under:
- Belgium · Imodium Duo
- Bulgaria · Имодиум Плюс
- Cyprus · Imodium Plus
- Czechia · Imodium Plus
- Germany · Imodium Akut Duo
- Denmark · Imodium Plus
- Spain · Fortasec Plus
- Finland · Imodium Plus
- France · Imodiumduo
- United Kingdom (Northern Ireland) · Imodium Dual Action Relief
- Greece · Imodium Plus
- Croatia · Imodium Combo
- Hungary · Imodium Plus
- Ireland · Imodium Plus
- Italy · Imodium Diarrea E Meteorismo
- Lithuania · Aloper
- Luxembourg · Imodium Duo
- Netherlands · Imodium Duo, Losimed Duo
- Norway · Imodium Comp
- Poland · Stoperan S
- Portugal · Imodium Duoeffect
- Romania · Imodium Plus
- Sweden · Dimor Comp, Imodium Plus
- Slovakia · Imodium Plus
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/2f0ca6be-54be-4eb5-a5b1-cdf1a683470c GET /v1/drugs/2f0ca6be-54be-4eb5-a5b1-cdf1a683470c?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"route": "ORAL",
"source": "ndc",
"strength": "2; 125",
"substance": "LOPERAMIDE HYDROCHLORIDE; DIMETHICONE",
"productndc": "50580-338",
"dosage_form": "TABLET",
"dea_schedule": null,
"strength_unit": "mg/1; mg/1",
"application_number": "NDA021140",
"marketing_category": "NDA"
}See everything about loperamide hydrochloride; dimethicone.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.